Guidance

Marketing authorisations for veterinary medicinal products (VMGN 2)

Veterinary medicines guidance note for the pharmaceutical and biological industries and companies that develop and market veterinary medicines.

This publication was withdrawn on

This guidance has been replaced by Marketing authorisations for veterinary medicines

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Marketing Authorisations for Veterinary Medicinal Products

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Details

Before placing a veterinary medicinal product on the market for sale or supply a valid marketing authorisation (MA) is a legislative requirement. These are granted by the Veterinary Medicines Directorate or by the European Commission. The holder of the marketing authorisation has to market that product in compliance with the terms of the authorisation.

The Veterinary Medicines Regulations permit certain medicinal products to be marketed without the need for an MA under schedule 6: exemptions for small pet animals. Further information can be found in Veterinary Medicines Guidance Note 12: exemptions for small pet animals.

An MA will be granted if the benefit:risk assessment is considered positive.

Published 30 April 2014